Johnson & Johnson Careers

Specialist Technical Data Architect

High Wycombe, United Kingdom; Ireland; Beerse, Belgium; Leiden, Netherlands
Clinical Data Management


Job Description

Requisition ID: 1905719637W

Specialist Technical Data Architect

Locations : UK (High Wycombe), NL (Archimedesweg), Belgium (Turnhoutseweg) or Ireland (Home Based)

 

The Pharmaceutical sector of Johnson & Johnson is now looking for a Specialist Technical Data Architect.

 

At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

 

The position is primarily accountable for providing expertise and delivery in technical clinical data management activities, including, CRF technical development, data stream integrations, data model specifications and mapping (SDTM or other), data quality review and submission-ready tabulation packages.  The position works together with the Global Data Managers to ensure the solutions are optimal to deliver the trial data content.  

 

This position analyzes, provides recommendations and makes decisions with minimal direction from manager.

Principle Responsibilities Include; Translate protocol requirements into optimal data capture approaches. Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for purpose data models and transfer intervals. Provide specifications and mapping for data models to be used for quality review and for final data model (SDTM or other). Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for Database lock and submission-ready tabulation packages.

 

Develop and maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc.) and apply continuous learning as data management platforms evolve.

 


Qualifications
Qualifications

Bachelor’s degree or equivalent work experience and strong experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc.).

In addition, the following competencies are required: 

  • In-depth knowledge of protocol, current clinical drug development processes
  • Knowledgeable of international guidelines regarding clinical trials end to end
  • In-depth knowledge of eDC systems 
  • In-depth SAS programming skills or other analytical programming language 
  • In-depth knowledge of SDTM including Define.xml, CDASH, metadata      
  • Ability to work with cross-functional team interpreting data requirements.
  • In-depth project management skills and knowledge of team management principles are required.
  • Vendor management oversight experience
  • Knowledge of reporting tools, e.g. Spotfire a plus
 
 


Primary Location
United Kingdom-England-High Wycombe-
Other Locations
Europe/Middle East/Africa-Ireland, Belgium-Antwerp-Beerse, Netherlands-South Holland-Leiden
Organization
Janssen Cilag Ltd. (7360)
Job Function
Clinical Data Management
Requisition ID
1905719637W